CancerVax Announces Retrospective Analyses of Phase 2 Data on Its Investigational Agent Canvaxin in the Treatment of Patients with Stage IV Melanoma.Business Editors/Health/Medical Writers BIOWIRE2K American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. 2004 Annual Meeting CARLSBAD, Calif.--(BUSINESS WIRE)--June 7, 2004 Data Presented at ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company Annual Meeting CancerVax Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CNVX) announced today that data from retrospective analyses show that treatment with Canvaxin(TM), the Company's investigational specific active immunotherapy active immunotherapy The administration of substances to evoke a protective immune response in the form of specific antibodies. Cf Passive immunotherapy, Vaccine. , significantly improved median overall survival of patients with Stage IV melanoma. Data were collected from 1,856 patients with Stage IV melanoma, 606 of whom received Canvaxin(TM) during Phase 2 clinical trials conducted at the John Wayne Cancer Institute (JWCI JWCI John Wayne Cancer Institute ). These data were presented on June 7, 2004 during the American Society of Clinical Oncology 2004 Annual Meeting in New Orleans, Louisiana. "The current prognosis for patients with Stage IV melanoma is poor, so we are encouraged by these analyses indicating that treatment with Canvaxin(TM) may improve survival," said David F. Hale, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CancerVax. "We are currently conducting two pivotal, Phase 3 clinical trials to evaluate our product candidate, Canvaxin(TM), for the treatment of Stage III and Stage IV melanoma at 80 clinical trial sites throughout the world." Donald Morton, M.D., Medical Director and Surgeon-in-Chief of the JWCI, presented a poster entitled "Active Specific Immunotherapy with a Polyvalent polyvalent /poly·va·lent/ (-va´lent) multivalent. pol·y·va·lent adj. 1. Acting against or interacting with more than one kind of antigen, antibody, toxin, or microorganism. 2. Cancer Vaccine Prolongs Survival in AJCC AJCC American Joint Committee on Cancer Stage IV Melanoma," which summarized retrospective analyses of data collected during Phase 2 clinical trials of Canvaxin(TM) conducted at JWCI. The median overall survival of 268 patients with Stage IV melanoma who received Canvaxin(TM) following the surgical removal of their tumors was 42.4 months, compared to 14.3 months for 170 historical control patients who did not receive Canvaxin(TM) following surgery. In an analysis of patients with Stage IV melanoma who did not undergo surgical resection of their tumors, median overall survival of 338 patients who received Canvaxin(TM) was 16.9 months, compared to 8.8 months for 1,080 historical control patients who did not receive Canvaxin(TM). The abstract is available on the ASCO web site (www.asco.org) and on CancerVax's home page (www.cancervax.com) in the "Focus" section. About Melanoma According to the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, , melanoma is the deadliest type of skin cancer and is the sixth most commonly diagnosed cancer in the United States. As reported by the World Health Organization, the worldwide incidence, or number of newly diagnosed cases, of melanoma in 2000 was 132,600, with 37,000 people dying of the disease. The American Cancer Society estimates that in the United States, approximately 55,000 people will be diagnosed with melanoma and 7,900 will die as a result of the disease in 2004. Furthermore, according to the National Cancer Institute, since 1997 the incidence of new melanoma cases in the United States has increased at an average rate of more than 5% per year, one of the highest growth rates Growth Rates The compounded annualized rate of growth of a company's revenues, earnings, dividends, or other figures. Notes: Remember, historically high growth rates don't always mean a high rate of growth looking into the future. for any type of cancer. In 2000, over 510,000 patients in the United States were alive who had been diagnosed with melanoma. About Canvaxin(TM) Canvaxin(TM), one of a new class of products being developed in the area of specific active immunotherapy, is based on a proprietary technology that may potentially be applied to treat a number of cancers. Canvaxin(TM) is polyvalent, expressing at least 38 tumor-associated antigens that may stimulate an immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. ; allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically , which may result in a stronger immune response, improved quality control and lower manufacturing costs than patient-specific immunotherapies; and is made of whole cells, which may stimulate a stronger immune response than other immunotherapy approaches that use cell fragments, peptides or antigens alone. Canvaxin(TM) has both orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the and fast track designations from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the treatment of invasive and metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. melanoma, respectively, and is currently being studied in two international Phase 3 clinical trials for the treatment of patients with Stage III and Stage IV melanoma. About CancerVax Corporation (www.cancervax.com) CancerVax Corporation is a biotechnology company focused on the research, development and commercialization of novel biological products for the treatment and control of cancer. The Company's lead product candidate, Canvaxin(TM), is one of a new class of products being developed in the area of specific active immunotherapy, also known as therapeutic cancer vaccines. Canvaxin(TM) is currently being studied in two international Phase 3 clinical trials for the treatment of patients with Stage III or Stage IV, or advanced-stage, melanoma. The Company is also finalizing the design of exploratory Phase 2 clinical trials for patients with other advanced-stage solid tumors (e.g., colon, renal, glioma glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. ). CancerVax also plans to identify and develop new product candidates based on its proprietary specific active immunotherapy, anti-angiogenesis and T-oligonucleotide, or telomere telomere /telo·mere/ (tel´o-mer) an extremity of a chromosome, which has specific properties, one of which is a polarity that prevents reunion with any fragment after a chromosome has been broken. homolog hom·o·log n. Variant of homologue. oligonucleotide, technology platforms, as well as on its human monoclonal antibody technology. CancerVax's corporate headquarters and research and development facility is located in Carlsbad, California and its biologics manufacturing facility is located in the Los Angeles, California area. Forward Looking Statements CancerVax cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by CancerVax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in CancerVax's business including, without limitation, statements about: the potential for its product candidates to result in marketable products; difficulties or delays in research, development, testing, obtaining regulatory approval, producing and marketing its technologies and product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of its product candidates that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its product candidates; its ability to meet product candidate development objectives; competition from other pharmaceutical or biotechnology companies; its ability to obtain additional financing to support its operations; its ability to attract and retain experienced scientists and management; and other risks detailed in CancerVax's Securities and Exchange Commission filings, including CancerVax's Annual Report on Form 10-K for the fiscal year ended December 31, 2003, and quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2004. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and CancerVax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. CancerVax(R) is a registered trademark of CancerVax Corporation. Canvaxin(TM) is a trademark of CancerVax Corporation. |
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